According to the CDC, 1 in 6 Americans become sick by eating contaminated food every year, resulting in an estimated 3,000 deaths. As if the human cost isn’t sobering enough, the Grocery Manufacturers Association also estimates the average cost of a recall to a food company is a whopping $10 million in direct costs in addition to brand damage and lost sales.

So, considering the growing public health and concerns the economic burden of foodborne illnesses, it made perfect sense when the 2011 Food Safety Modernization Act shifted the FDA’s focus from simply responding to food safety problems to trying to prevent them. FSMA now requires food facilities to conduct a comprehensive hazard analysis and then establish risk-based preventive controls. For a number of facilities, color-coding has become one of the preventive controls to protect food against direct contamination, cross-contact, and cross-contamination incidences.

Benefits of Color-Coding as a Preventive Control

Color-coding is prized as a preventive control for its ability to easily and quickly communicate information essential for food safety. Colors can signal the process status – visualize the traffic lights and what each color communicates to a driver. The same concept could apply to material handling across process flows and act as a signal for whether the product should move to the next process level or not.

More importantly, colors act as visual cues or identify the personnel, equipment or tools within an area. If blue-bristled pipe brushes are used for cleaning food conveyance pipes, and black-bristled tube brushes are used for clearing drains, there is a clear identifier between food-contact and non-food contact tools to prevent accidental misuse.

The other function of color-coding is that colors can separate the zones and products based on risk. Something as simple as red and blue storage tubs could easily separate low-risk raw meat from high-risk processed product to prevent cross-contamination. It can also be used to separate allergen zones.

Color-Coding as a Preventative Strategy

There are three main ways a color-coding plan can fit into a food safety management system:

1. As Part of the Standard Operating Procedures: A color-coding plan can specify the colors used for scoops for handling different products within an Allergen SOP, or cleaning brushes to be used for different surfaces within a Sanitation Standard Operating Procedure (SSOP).
2. As a Preventive Control within a Food Safety Plan: For this, the plan must be validated or justified, monitored, verified, and reviewed as a food safety control.
3. As a Standalone Color-Coding Plan: This could reference other procedures and can also follow the same format as the food safety plan.

The facility may decide to reference color-coding within their Current Good Manufacturing Practices (cGMPs), Preventive Controls, or Best Practices framework as long as there’s consistency and a clear process of justifying, verifying, and reviewing the program.

Developing a Color-Coding Plan

The steps to establishing any preventive controls are as follows:

1. Conduct a Comprehensive Hazard Analysis: Do you have areas where there’s a chance of allergen cross-contact or cross-contamination? These could be the right place to establish color-coding zones or use color-coded implements.
2. Evaluate the Applicability of Color-Coding: Will color-coding prevent issues? If you need to identify a way of keeping scoops separated, it would be an appropriate use of color-coding as a preventive control. If raw product is touching finished product because there isn’t enough workspace, color-coding may not help.
3. Establish Control Measures, Preventive Controls, and Practices: Color-coding strategy may be employed as part of the current Good Manufacturing Practices, or as a risk-based Preventive Control, or as an industry best practice.
4. Set the Monitoring, Corrective Action, Verification, and Review Criteria for the Plan: For monitoring, process leaders and managers can effectively watch out for colored-tools being used in the wrong zones. Corrective actions vary from putting affected products on-hold to retraining specific employees. Verification comes through pre-operational inspection and being on the floor to see that the right tools are being used at the right zones. Review the criteria for the plan to ensure it’s working and still fits the need in that area.
5. Education, Train, and Refresh the Employees on the Plan: Workers should be reminded through continuous education, and retrained on color-coding at least yearly, or whenever there are changes to the plan.

Evaluating Risks with the Hazard Analysis Cube

The Hazard Analysis Cube is one way of visually identifying the three key variables essential for a comprehensive hazard evaluation:

The Food Safety Hazard refers to the type of contaminant i.e. biological, chemical or physical, that may adversely affect food.

Though stating the hazard is still key to the process, FSMA moves hazard analysis beyond this fundamental.

The Mode of Hazard Introduction clarifies how the hazard was introduced—whether it was accidental, naturally occurring in the product, or deliberately added by malicious agents.

The Focus Point of Control refers to where the control strategies to prevent the hazards are put into place. Is it at the lower tier for materials, ingredients, or product, or at a higher level involving processes and personnel practices, or at a much higher, systematic and environmental level?